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The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.

The Stylus (may also be referred as Stylet, Introducer, Obturator or Stiffener) is an Introducer for the Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button (LPGFT/B - K122030) originally cleared in July 2012 which was developed at Degania Silicone Ltd. The Stylus is made of Polycarbonate (Macrolon®) and has various ranges of lengths, colors and weights. The Stylus is inserted all the way into the Feeding Port of the LPGFT/B port of the cleared gastrostomy device. The use of the Stylus is optional, it provides stiffness to the LPGFT/B shaft to guide the LPGFT/B through the stoma. The Stylus should not exceed the buttons distal tip. The Stylus is being sterilized by Ethylene Oxide (EtO) along with a compatible Low Profile Gastrostomy Feeding Tube/ Gastrostomy Button kit, rather than a standalone device.

The provided text describes the "Stylus" device, which assists in placing gastrostomy feeding tubes. The 510(k) summary (K233591) details its regulatory information and a brief overview of testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study specifics.

Based on the available text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Bench Performance Testing" that included:

• Tensile strength testing
• Stylus stiffness testing
• Dimensional testing
• Gastrostomy compatibility testing

The reported performance conclusion is: "The results show that the device is at least as [effective as] a legally marketed predicate device."

However, the specific numerical acceptance criteria or the quantitative results for these tests are not provided in the given text. A table cannot be generated without these details.

2. Sample size used for the test set and the data provenance

The document states, "Bench Performance Testing included tensile strength testing, styls stiffness testing dimensional testing, and gastrostomy corpatibilitytesting." However, no details about the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective) are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not mentioned in the provided text. The testing described appears to be bench testing, not involving human interpretation or ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human assessment or interpretation, which is not described for this bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not mentioned in the provided text. The device described, the Stylus, is a physical introducer for feeding tubes, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the Stylus is a physical medical device, not an algorithm or software. The testing mentioned is device performance testing, not algorithm performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench performance tests mentioned (tensile strength, stiffness, dimensions, compatibility), the "ground truth" would be the engineering specifications and established physical measurement standards relevant to the device's function and comparison to the predicate. The document doesn't explicitly state "ground truth" in this context but implies a comparison to predicate device performance.

8. The sample size for the training set

The Stylus is a physical device and not an AI/ML model, so there is no training set in the context of machine learning. The testing described is physical performance testing.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

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